MAUDE Adverse Event Report: ULTRADENT PRODUCTS, INC. VALO CORDLESS BATTERY CHARGING UNIT

Model Number 5962

Device Problem Environmental Compatibility Problem (2929)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2017

Event Type  malfunction  

Event Description

An email was received on (b)(6) 2017 from a dentist in (b)(6) in regards to a fire that occured a month prior (exact date unknown at this time) at a naval dental clinic in (b)(6).The dentist was asking what we could tell him about a fire that may have occured due to a valo battery charger over heating.After a review of the complaint data base and employee interviews we determined we had no prior knowledge of this event and a call was placed to the facility were we were told it occured.The person at the clinic informed our government accounts manager that he did not have all the information and would call our complaints department.Our customer satisfaction manager did make contact with the two people involved with the fire investigation, the following is known at this time:+ · the fire started at 2:00 am on (b)(6) in the (b)(6) clinic.These are old navy buildings with old wiring.· the source of the fire was definitely from the area of the battery charger in an additional room in the clinic.· an assistant plugged two battery charging units into the same wall outlet and sat the chargers on a metal table.· it was burned inside the wall by the battery charger.· the clinic has over 100 chargers with batteries.They charge 1-3 hours every 2 wks.As of september 09, 2017 nobody from the clinic involved has made contact.Phone call to facility on september 12th 2017- they were not authorized to give us any information.If further information is obtained mdr will be updated if needed.Filing an mdr out of an abundance of caution in the event valo was involved.

• Brand Name: VALO CORDLESS BATTERY CHARGING UNIT
• Type of Device: VALO CORDLESS BATTERY CHARGING UNIT
• Manufacturer (Section G): ULTRADENT PRODUCTS, INC.; 505 w ultradent drive; south jordan UT 84095
• Manufacturer Contact: 505 w ultradent drive; south jordan, UT 84095 ; 8015534500
• MDR Report Key: 7139680
• MDR Text Key: 95959131
• Report Number: 1718912-2017-00044
• Device Sequence Number: 1
• Product Code: EBZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5962
• Device Catalogue Number: 5962
• Device Lot Number: UNABLE TO OBTAIN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other